Senior Manager Regulatory Affairs
As a QA & RA Compliance Manager within the Marketing Review Services (MRS) department at REJIMUS, INC. a preeminent regulatory management consulting firm to the Food & Beverage, Dietary Supplement, Animal Feed, Cosmetic and Homeopathic industries, you will be responsible for providing regulatory review expertise, project/task ownership, management support as requested or assigned and support for clients as directed in areas such as manufacturing operations, product development support, labeling and marketing reviews, claim substantiation, claims reviews, labeling design/development, scientific research, regulatory due diligence, formulation reviews, quality documentation review/development, and support for report drafting and reviews of reports and marketing copy. You will organize regulatory information, track and control documentation, proof-read and provide input on compliance works in accordance with daily operating practices of REJIMUS and the regulations as cited under the applicable regulations relevant to the task(s)/project(s) assigned.
- Lead by example in the development and execution of regulatory strategy that includes a continued awareness, understanding and pro-active response to FDA regulations, guidance documents, and enforcement actions. Implement standards for and oversee technical review and organization of documentation to meet USDA, FDA and FTC requirements for the marketing of client products (including dietary supplements, foods, beverages, personal care products and cosmetics)
- Implement and oversee systems for product labeling and label claims to ensure US FDA requirements are met
- Implement and oversee systems for the preparation of substantiation documents to support product label and advertising claims
- Work directly with cross-functional teams, including product development, marketing, legal counsel, regulatory consultants and government agencies in order to register the company’s products and comply with applicable regulations and laws
- Ensure that marketing materials are compliant in relevant markets and channels and maintain/manage documentation files
- Coordinate with Project Managers regarding regulatory timelines and risks
- Have a working knowledge of relevant product laws and regulations
- Coordinate with other employees/consultants as needed to help obtain registration of products in global jurisdictions
- Provide input in to raw material and finished product specifications
- Develop Risk Management plans
- Ensure FDA requirements are observed and understood, e.g., 21 CRF Part 101, 21 CFR Part 111, and 21 CFR Part 117 for all appropriate systems they support, as well as critical documentation.
- Manage required product testing including but not limited to Proposition 65 compliance, certifications and specifications
- BS/BA is required. MS, PharmD, Ph.D., or MD preferred. (not necessary)
- Minimum of 10 years experience in a Regulatory and or Quality Assurance leadership role
- Five years or more of relevant experience with Dietary Supplements and all aspects of DSHEA requirements
- Experience with developing regulatory strategy for dietary supplements, foods, and cosmetics, including claims, labeling, and claim substantiation
- Experience with development of Quality Assurance standards and audit function
Base Pay: $80k/yr – $100k/yr
Additional Compensation Range: $20k/yr – $40k/year
If you are interested in applying for this position, please email your resume to email@example.com.